Glaucoma | Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension
Glaucoma research study
What is the primary objective of this study?
This efficacy and safety study will evaluate LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL GFS, 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.
Who is eligible to participate?
Inclusion Criteria: - Ocular hypertension or glaucoma that requires treatment with medication - Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes Exclusion Criteria: - History of LASIK, LASEK, RK, and/or PRK in the study eye(s) - History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months - Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:bimatoprost 0.01%Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.
Drug:travoprost 0.004%Travoprost 0.004% administered to both eyes once daily for 12 weeks.
Drug:timolol 0.5%Timolol 0.5% administered to both eyes once daily for 12 weeks.
Drug:hypromellose 0.3%Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
bimatoprost 0.01% and hypromellose 0.3%Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
travoprost 0.004% and timolol 0.5%Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
Start Date: May 2014
Completed Date: December 2014
Phase: Phase 4
Primary Outcome: Intraocular Pressure (IOP) in the Study Eye at 8 AM, 12 PM, and 4 PM
Study sponsors, principal investigator, and references
Principal Investigator: Medical Director
Lead Sponsor: Allergan